Clearance Summary
CRITERION II RHYTHM PROFILE MONITOR received FDA 510(k) clearance under submission number K803315, sponsored by Dart Medical Equipment. The device was reviewed via the Traditional premarket notification pathway and assigned to the Cardiovascular review panel. The statutory decision date of record is 1981-01-22.
- Submission: K803315
- Applicant / Sponsor: Dart Medical Equipment
- Clearance pathway: Traditional
- Review panel: Cardiovascular
- Device class: Class II
- Regulation citation: 21 CFR 870.2920
- Decision date: 1981-01-22
Classification & Regulation
This clearance is catalogued under FDA product code DXH and 21 CFR 870.2920, within the Cardiovascular review panel as a Class II device.